Force Health Protection
USAMMDA Force Health Protection Division (FHP), on behalf of the Secretary of the Army as Lead Component and the Surgeon General of the Army under DoD Instruction (DoDI) 6200.02, provides an urgent treatment, diagnostic or prophylactic capability against high consequence threats when FDA-approved products are unavailable, are contraindicated, or are not effective.
In this role, FHP:
- Facilitates Investigational New Drug (IND) and Emergency Use Authorization (EUA) product use approval by the Assistant Secretary of Defense for Health Affairs (ASD(HA)), as required by DoDI 6200.02.
- Establishes and manages FDA-compliant protocols, product procurement, shipment and inventories, and regulatory reporting, and interfaces with the U.S. Army Medical Research and Development Command Institutional Review Board as the IRB of record for DoDI 6200.02 protocols to enable execution of protocols worldwide, during emergent events or contingency operations.
- Partners with other federal advanced developers and the Centers for Disease Control and Prevention (CDC) to identify products for portfolio inclusion.
- Some FHP protocols address low-probability/high-consequence biothreat-related diseases.
- Others provide a means to treat conditions endemic in areas important to the DoD.
Indications Addressed by FHP Expanded Access and Emergency Use Protocols
|DoDI 6200.02 Protocols||Indication||FHP IND Capabilities in Action|
|Biothrax® (Anthrax Vaccine, Adsorbed) with antibiotics||Anthrax Post-Exposure Prophylaxis|
|Pentavalent Botulinum Toxoid Vaccine||Vaccination against botulinum toxin exposure||2002|
|IV Cidofovir||Orthopoxvirus infection, including smallpox|
|Tecovirimat (ST-246)||Orthopoxvirus infection, including smallpox||2014, 2016 (vaccinia reactions)|
|IV Arbekacin||Multidrug-resistant bacterial infection|
|IV Ribavirin||Lassa Fever|
|Hemorrhagic Fever with Renal Syndrome
|2013 (Dobrava virus)
2005 (Hantaan virus)
|Congo-Crimean Hemorrhagic Fever||2009|
|IV Pentostam (Sodium stibogluconate)||Leishmaniasis (all forms)||2004-2010
(multiple cases of cutaneous leishmaniasis)
|IV Artesunate||Severe falciparum malaria||2011, 2014 (2), 2015|
|Freeze-dried Plasma||Severe hemorrhage/trauma||2012-2017|
|Antivenoms (species specific)||Snakebite/Scorpion sting||2006-2013 (multiple cases in CENTCOM)|
|Stamaril (French Yellow Fever Vaccine)||Vaccination against yellow fever virus|
* Emergency Use Authorizations allow use of unapproved products for large populations in the event of a declared public health emergency.
* Expanded Access IND Protocols enable treatment of intermediate sized populations with instructions on FDA-compliant product use and safety data reporting to ensure the best possible support to DoD personnel. Product can be pre-positioned under controlled release where it is most likely to be needed, especially where timing of treatment may be critical.
* Individual Patient Expanded Access IND Requests facilitate rapid response to life-threatening conditions for which no other response is available for individual patients.